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This document discusses monophasic liquid dosage forms. It defines monophasic liquid dosage forms as liquid preparations containing components in a single phase system, typically a true solution. Water is mainly used as the solvent. Monophasic liquids can be for internal use like syrups or external use like lotions. They have advantages like easier swallowing and faster absorption but also disadvantages like being bulky and requiring preservatives. The document outlines common additives used like stabilizers, antioxidants, coloring agents, flavorings, and their roles in formulations. Specific dosage forms discussed include gargles, mouthwashes, and throat paints.

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Monophasic liquid dosage forms include solutions for internal and external use, offering benefits like easier swallowing and uniform dosing, but also have drawbacks such as bulkiness and stability issues.

Additives such as stabilizers, preservatives, and antioxidants are crucial for preventing degradation and ensuring the stability of monophasic liquid formulations.Coloring agents, both natural and artificial, enhance the appearance of formulations for aesthetics and stability, with ideal properties ensuring safety and compatibility.

Flavoring agents enhance taste and palatability of oral medications, categorized into natural and artificial, with specific examples listed for each.

Gargles, mouthwashes, and throat paints are liquid preparations for treating infections, with compositions including antiseptics, astringents, and flavoring agents.

Ear and nasal drops are liquid preparations for local effects, utilizing various active ingredients for antibacterial and therapeutic purposes while ensuring proper formulation.

Enemas are aqueous or oily solutions for rectal administration, used for bowel evacuation or therapeutic effects, categorized into evacuant and retention types.

Collodions are solutions containing pyroxylin for skin application, used for binding or protecting small wounds, classified into medicated and non-medicated types.

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Monophasic liquid dosage form Monophasic liquid dosage form refers to liquid preparation containing two or more components in one phase system, it is represent by true solution. •The component of the solution which is present in a large quantity is known as "solvent", whereas the component present in a small quantity is termed as "solute". Water is mainly used as solvent for majority of monophasic liquid dosage forms. A solution is homogenous because the solute is in an ionic or molecular form of subdivision.
Monophasic liquid dosage forms are available as:- 1 .Liquid for internal use e.g. Syrup, Elixirs, Linctus, Drops and draughts. 2. Liquid for external use, which are of two types: a)Liquid to be applied to the skin e.g. liniments, and lotions etc. b)Liquid meant for body cavities e.g. gargles, throat paints, mouth washes, eye drops, eye lotions, ear drops, nasal drops, sprays and inhalations.
Monophasic liquid dosage forms Liquid for internal use Eg: Syrup, Elixirs, Linctus, Drops and draughts. Liquid for external use Liquid to be applied to the skin Eg: liniments, and lotions b)Liquid meant for body cavities Eg: gargles, throat paints, mouth washes, eye drops, eye lotions, ear drops, nasal drops, sprays and inhalations.
Advantages of Monophasic liquid dosage forms • It is easier to swallow, therefore easier for children and old age people. • Facilitate absorption of drug faster than solid dosage form as drug is already in solution form.
• It is homogenous therefore give uniform dose than suspension or emulsion which need shaking. • Simple and fast to formulate • It can be administered by various routes : Oral, Parenteral (injection),enema for rectal use, otic(ear), nasal and ophthalmic preparation.
Disadvantage • They are bulky, so difficult to transport and store. • Water is commonly use vehicle, which is prone to microbial growth. So addition of preservative is needed. • When expose to direct sunlight it may undergo hydrolysis, so need to store in cool and dark place. • Drug stability reduce by hydrolysis or oxidation. So, they have shorter expire date than solid dosage form. • Other major sign of drug instability are color change, Precipitation, microbial growth etc.
Additives used in Monophasic Dosage form: Stabilizers: The compounds that protect the formulation from chemical degradation or microbial spoilage are termed as stabilizers. Antioxidants and preservatives are good stabilizers which are used in pharmacy. Stabilizers Preservatives Antioxidant
Antioxidants: Antioxidants are the compounds which prevent oxidation of the drug by different mechanisms. Oxidation of the drug is the most serious change. A large variety of drugs undergo oxidation degradation they are: Ascorbic acid, Heparin, Reserpin, Neomycin, Vitamin A, D & E etc. Every time a molecule is oxidized another molecule simultaneously gets reduced.
Another classification of antioxidants are
The oxidants are mostly used in food, drug and cosmetic preparations, Other antioxidants used are: Benzoin Citric acid Malic acid etc. Malic acid is used as a rancidity retardant for oils and fats. Synergists: Synergists are compounds that enhance the overall effectiveness of the antioxidant compounds. This is achieved in the following ways: a. Complexation of the trace metals that catalyse the oxidative breakdown. b. Decreasing the oxygen stability of the solutions. The use of antioxidant to prevent oxidation is a popular practice but sometimes they shows toxicity. Eg: Thiol Derivatives. Choice of antioxidants: Following should be taken care while selecting antioxidants: 1. Must be nontoxic 2. Must not interfere with organoleptic property of the product 3. Inert in nature 4. Solubility should be proper.
Colouring agents: A colouring is any substance that is added to change formulation colour. One of the most obvious ways to influence the way a product looks is to add colouring agents. Colorants or coloring agents are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms. These range from “natural” and artificial colours. Natural Colour A growing number of natural food colourings are being commercially produced, partly due to consumer concerns surrounding synthetic colourings. Some examples include: • Caramel colouring, made from caramelized sugar, used in cola products and also in cosmetics. • Annatto, a reddish-orange dye made from the seed of the Achiote. • A green dye made from chlorella algae. • Cochineal, a red dye derived from the cochineal insect, Dactylopius coccus. • Betanin extracted from beets. • Turmeric • Saffron • Paprika • Elderberry
Pharmaceutical preparations are colored for following reasons: 1) Increases acceptability 2) For identification - It helps to identify a product in it manufacturing and distribution stages 3) Stability purpose - Some of the insoluble colors or pigments have the additional benefit when used in tablet coatings or gelatin shells of providing useful opacity, which can contribute to the stability of light‐sensitive active materials in the tablet or capsule formulation.
Ideal properties of a colorant • Non-toxic and have no physiological activity. • Free from harmful impurities • Unaffected by light, tropical temperatures, hydrolysis and micro‐organisms and, therefore, be stable on storage. • Unaffected by oxidizing or reducing agents and pH changes. • Compatible with medicaments and not interfere with them. • Ready solubility in water is desirable in most cases but some oil‐soluble and spirit‐soluble colors are necessary. • Does not interferes with the tests and assays to which the preparations containing it are subject. • Free from objectionable taste and odour.
Artificial colouring The colours below are known as “Primary Colours”, when they are mixed to produce other colours, those colours are then known as “Secondary Colours”. *Brilliant Blue, E133 (Blue shade) * Indigotine, E132 (Dark Blue shade) * Fast Green, E143 (Bluish green shade) * Allura Red AC, E129 (Red shade) * Erythrosine, E127 (Pink shade) * Tartrazine, E102 (Yellow shade) * Sunset Yellow, E110 (Orange shade) Inorganic or mineral colors Stability towards light is an important characteristic displayed by this materials, some of which have a useful opacifying capacity, e,g. Titanium dioxide.
• Dyes and Lakes Colour additives are available for use in drug formulations as either “dyes” or “lakes”. Dyes dissolve in water, but are not soluble in oil. Dyes are manufactured as powders, granules, liquids or other special purpose forms. They can be used in beverages, dry mixes, baked Goods, dairy products, pet foods and a variety of other products. Lakes are the combination of dyes and insoluble material. Lakes are not oil soluble, but are oil dispersible. Lakes are more stable than dyes and are ideal for colouring products containing fats and oils or items lacking sufficient moisture to dissolve dyes. Typical uses include coated tablets, cake and donut mixes, hard candies and chewing gum.
ARTIFICIAL COLOURANTS Colouring agent Description Colour Erythrosine Solid,fine powder Red Sunset Yellow Solid,fine powder Reddish Orange tartrazine Solid,fine powder Light orange Ponceau Solid,fine powder Red Allura red Solid,fine powder Deep red amaranth Solid,fine powder Rediish brown Indigo carmine Solid,fine powder Bluish brown Brilliant blue Solid,fine powder Bluish violet Quinoline yellow Obtained from coal tar Yellow to orange powder
Colouring agent Description Colour Paprika Clear dark red oily liquid, Dark red Annatto Crystalline powder Bright Yellow To Orange red Caramel Thick liquid Dark brown Carotene Powder, crystals Red to Brown Curcumin Crystal form Orange yellow Riboflavin Fine powder in needle form Whitish yellow Carmine Powder form Bright red Curcumin Crystal form Orange yellow NATURAL COLOURANTS
Flavouring agents: A flavor, as used in the pharmaceutical industry for inactive ingredients, refers to natural or artificial tastes, which may include fragrances and colors of the flavoring. Flavors are used for orally consumed products such as syrups, chewable tablets, suspensions, or gums in order to make the bitter taste of the medicine more palatable, as well as imparting a beneficial therapeutic effect. Pharmaceutical flavors are available in liquid or powder form, in a variety of concentrations, formulations and sizes. Standard formulas are available as certified kosher, organic, vegan, all-natural, natural/artificial, artificial and sugar-free.
Flavouring agents are added to increase patient acceptance. The four basic taste sensations are salty, sweet, bitter and sour. It has been proposed that certain flavours should be used to mask these specific taste sensations. Example: Clove oil, citric and syrup, glycerin, rose oil, orange oil, menthol etc
Natural flavouring substances are extracted from plants, herbs and spices, animals, or microbial fermentations. Essential oils and oleoresins that are created by solvent extract with the solvent removed, herbs, spices and sweetness are all natural flavourings. Natural flavourings can be either used in their natural form or processed form for human consumption and they cannot contain any nature-identical or artificial flavouring substances.
Artificial flavouring agents are chemically similar to natural flavourings but are more easily available and less expensive. However, one drawback is that they may not be an exact copy of the natural flavourings they are imitating like amyl acetate which is used as banana flavouring or ethyl butyrate for pineapple. Nature-identical flavouring agents are the flavouring substances that are obtained by synthesis or are isolated through chemical processes. There chemical make-up of artificial flavourings is identical to their natural counterparts. These flavouring agents cannot contain any artificial flavouring substances.
Chemical Odor Diacetyl, acetylpropionyl, acetoin Buttery Isoamyl acetate Banana Benzaldehyde Bitter almond, cherry Cinnamaldehyde Cinnamon Ethyl propionate Fruity Methyl anthranilate Grape Limonene Orange Ethyl decadienoate Pear Allyl hexanoate Pineapple Ethyl maltol Sugar, cotton candy Ethylvanillin Vanilla Methyl salicylate Wintergreen Manzanate Apple
Gargles: Gargles are aqueous and hydroalcoholic solution which is used to treat or prevent throat infection. It is used in the posterior region of mouth by agitating the solution with exhaled air to produce local effect in the throat and these are not to swallowed in large amount. They are dispensed in concentrated form with directions for dilution with warm water. They are brought into intimate contact with the mucous membrane of the throat and allow to remain for few moments. Formulation: The commonly used active ingredients in gargle include Antiseptics, Analgesics, Astringents, and Alkalizing agent. Common drugs include phenol, thymol, menthol, methyl salicylate, povidone- iodine etc. Phenol and thymol is generally present in small concentration for its antibacterial activity. Astringent helps to restore tune of relaxed throat and also relieves dryness by stimulating salivation.
Some gargles like the Phenol Gargle and Phenol and Potassium Chlorate Gargle are official in BPC. Phenol gargle is 5% v/v solution of phenol and glycerin (16% w/w phenol and 84% w/w glycerin) in water containing amaranth dissolved in chloroform water. Gargles ought to have acceptable organoleptic properties and should be designed to act fast because of short contact periods. At the same time they should not be irritating to the mucous membranes of the oral cavity. Glycerin is the choice of vehicle for gargles, the reasons are as follows: a. Due to viscosity, it keeps medicament in contact with membraneous lining of throat for long period. b. Acts as demulcent c. The sweet taste of glycerin with aromatic substances in gargle gives characteristics flavor. d. It can increase the solubility of drug in the system.
The following ingredients are used in the formulation of Gargles Drugs Antiseptics, antibiotics etc Colouring Agents Amaranth, Patent blue V Flavouring Agents Peppermint oil Sweetening Agents Sucrose Viscolizers Glycerin Preservatives Phenol, thymol Vehicles Water, chloroform water
Potassium Chlorate and Phenol Gargle Rx Potassium Chlorate Liquefied Phenol Patent Blue V Water Potassium chlorate and phenol gargle BPC is used as an astringent and antimicrobial. Potassium chlorate acts as a mild astringent and liquefied phenol acts as an antimicrobial agent Potassium chlorate is soluble in water and phenol is miscible with water. Therefore this gargle is prepared by simple dissolution of potassium chlorate in water followed by liquefied phenol and finally addition of patent blue V. Category: Astringent, antimicrobial Dilute 10 times with warm water before use.
Mouth washes These are aqueous solutions with a pleasant taste and odour used to make clean and deodorise the buccal cavity. Generally they contain antimicrobial agents, alcohols, glycerin, sweetening agents, flavouring agents and colouring agents. Mouth washes are formulated either in ready to use form or in concentrated form. Mouth wash in concentrated form are required to be diluted as per directions on label. A pH of 5 – 9.5 appears to be safe range with 6.5 – 7 being optimum for liquids for oral use.
Ingredients used in the formulation of mouth washes are Ingredients Category Examples Drugs Antibacterial agents Phenols, thymols, tannic acid Astringents Zinc sulphate Antiseptics Hexitidine Viscolizers/ Humectants Glycerin, sorbitol Surfactants Tweens, Spans, SLS Sweeteners Saccharin Flavours Peppermint, cinnamon Colorants Amaranth Vehicles Water, Alcohol
Mouth Washes Cosmetic Mouthwashes Therapeutic Mouthwashes Mouth washes are used as a dosage form for a number of specific problems in the oral cavity. Mouthwashes containing antibacterials: These reduce bacterial population of the mouth Mouthwashes containing fluorides: These helps to reinforce the fluoride layer of the enamel of the teeth Mouthwashes containing astringents: These precipitate the protein of microorganisms and thereby helps in throat infections. These are formulated to reduce bad breath through the use of antimicrobial and / or flavouring agents. Eg: Soap based mouthwashes. Cosmetic mouthwashes remove superficial for particles and debris and they are very refreshing Classifications:
Therapeutic mouthwashes are used for the following reasons: a. Used in the treatment of stomatitis b. Mouthwash containing pilocarpine is used in xerostoma (dry mouth) etc Nowadays mouthwash solution tablets are available. These tablets are dissolved in water and used as mouthwash.
Compound Sodium Chloride Mouth Wash BPC Rx Sodium Chloride Sodium bicarbonate Peppermint emulsion, concentrated Chloroform water, double strength Water Compound sodium chloride mouthwash is used as an astringent. Sodium chloride and sodium bicarbonate are soluble in water. Concentrated peppermint emulsion and chloroform water are miscible with water in the quantities specified in the formula. Therefore this mouthwash is prepared by dissolving the solid ingredients and simple mixing is sufficient. In this preparation peppermint emulsion acts as a flavouring agent. Chlorofom acts as a preservative and sweetener. Dilute with an equal volume of water before use.
Throat paint Throat paints are the viscous liquid preparations used for the mouth and throat infections. Glycerin is commonly used as a base. Paints can be applied onto skin and mucous membranes. Throat paints are made viscous because, they should remain in contact with mucous membrane, to exert its medicinal action for longer time. Therefore glycerine is commonly used as a base(vehicle) due to its viscous nature and its agreeable sweet taste and cooling effect. Throat paints are applied to the affected part with the help of camel hair brush or by cotton plug, twisted at the tip of plastic stick. They should be applied as such, without dilution with water.
Medicaments used in Throat paints: 1) Astringents : Tannic acid, Boric acid 2) Antiseptics : Iodine, Crystal violet 3) Anti- infectives : Phenol 4) Analgesics : Clove oil, Potassium permangan Examples for throat paints : Mandl ’ s paint(compound iodine paint) Tannic acid- glycerine throat paint Phenol- glycerine throat paint ate
Advantages : Throat paints are useful in the treatment of pharyngitis, laryngitis , tonsillitis thrush, abcess of throat and ulcerative stomatitis . Due to high viscous nature, they retain the drug for longer time on affected part of the throat. Disadvantages : Throat paints initiate salivation. Hence the patient has to spit again and again till salivation subsides. This makes it uncomfortable to the patients It is very difficult to apply the throat paint to the inner parts of the mouth and throat by the fingers. Hence always requires camel hairbrush or cotton plug, twisted at the tip of plastic stick for application of throat paint. This makes it difficult and uncomfortable to the patients .
Formulation : Along with the medicaments, it contains high proportions of glycerine and other sweetening agents , flavouring agents, stabilizers and preservatives. Method of preparations: They are preparations by simple solution method , with the aid of heat. Dispensing : Throat paints should be dispensed in air tight , coloured (amber coloured -light sensitive), narrow or wide mouthed bottle in order to distinguish them from the preparations meant for internal use and they should be supplied with camel hairbrush(throat brush.)
Direction: Throat paints should contain the direction to the patients as, Apply with camel brush, as directed. To prevent their volatalisation at higher temperature , they should be stored in a cool and dark place.
COMPOUND IODINE THROAT PAINT I.P Synonym : Mandl’s paint Rx Potassium iodide Iodine Alcohol Purified water Peppermint oil Glycerine Iodine is slightly soluble in water, but it is soluble in presence of potassium Iodide and forms polyiodides. These polyiodides are highly soluble in water and hence produce monophasic liquid. Alcohol(90%) acts as cosolvent , to increase the solubility of iodine. It is also used to dissolve peppermint oil, which acts as flavouring agent. Glycerine is viscous in nature hence Mandl’s paint will remain in contact with mucous membrane of throat for longer time, It also acts as humectant and soothing agent. .
Procedure: Triturate iodine in glass mortar, to get fine powder and accurately weigh the required amount of iodine. Dissolve potassium iodine in water. To this solution, add iodine powder by stirring . Dissolve peppermint oil and half of the portion of the portion of glycerine in alcohol. Add this solution to the above iodine and potassium iodide solution ,with continuous stirring and adujust the final volume with remaining portion of glycerine . Uses : Mandl ’ s paint is used in the treatment of pharyngitis, laryngitis, tonsillitis and sore throat.
Ear drops Ear drops are medicated liquid preparations and these are used for instillation in to ear with the help of a dropper. The solution are prepared in water, glycerin, propylene glycol or alcohol. Vehicle like glycerin and propylene glycol are preferred as they increase contact time and soften the wax. Aqueous solutions are less popular because the secretions in the ear are mainly fatty and aqueous solutions do not easily mix with them. Uses of Ear Drop 1. Antibacterial. 2. Softening the wax. 3. Mild infections
The main classes of drugs used in ear drops are a. Bacterial infections are sometimes treated with antibiotics. Examples are: • Ciprodex ear drops containing ciprofloxacin and dexamethasone • Gentisone HC ear drops containing gentamicin and hydrocortisone • Ciproxin HC ear drops containing ciprofloxacin and hydrocortisone b. Analgesics: Salicylic acid c. Antiseptics: Phenol d. Astringents: Alumenium Sulphate. For softening the ear wax: Hydrogen peroxide, magnesium sulphate.
Eg: Boric Acid Ear Drop Rx Boric Acid Industrial Alcohol Purified Water QS Make ear drop Two to three drops to be instilled in to ear, as directed. Boric acid is a week germicide (antiseptic), which inhibits the growth of certain bacteria and fungi. It is also used to treat otorrhoea. It is nonirritating in nature. Therefore it is suitable for penetrating ear drops. Boric acid is slightly soluble in water but is freely soluble in industrial alcohol (alcohol 95%). Alcohol also acts as preservative.
Procedure: Ear drops are prepared by simple solution method with or without aid of heat. 1. Accurately weighed boric acid is dissolved in industrial alcohol 2. To the above solution add 3/4th of total volume of purified water and mix thoroughly. 3. Filter the solution to remove any foreign particles or undissolved substances. 4. Transfer this content to a measuring cylinder and add sufficient amount of water to make up the final volume. Storage: Transfer the solution to a small glass or plastic bottle of 10-15 ml capacity, close it thoroughly with rubber closure and aluminum cap, polish, label and supply with a dropper. For external use only or for ear use only
Nasal drops Nasal drops are aqueous preparations of drugs, intended for instillation into nostrils with the help of a dropper. They are generally used for their antiseptic, local analgesic or vasoconstriction properties. Medicaments commonly used are: Medicaments commonly used are: Anti-inflammatory : corticosteroids, betamethasone. Sympathaomimetics :Ephedrine hydrochloride Decongestants :phenylephrine, oxymetazole,Tetrahydrozoline hydrochloride , oxymetazole hydrochloride
Nasal drops are generally formulated to resemble the nasal secretion. Hence nasal drops should be isotonic and slightly buffered, to maintain pH 5.5 – 7.5 . The viscosity of nasal drops should be similar to the viscosity of the nasal secretions. Therefore viscosity of nasal drops is adjusted with the help of thickening agents like methylcellulose, hydroxy propyl methylcellulose For preparation of nasal drops, generally aqueous vehicles is used . Oils are not preferred as vehicles, because oily drops inhibit the ciliary movement of the nasal mucosa and even causes lipoidal pneumonia (drops of oil enters the lungs). Since the nasal drops is instilled in to nasal cavity , that will be in contact with mucous membrane of nose , it should be clarified by passing through sintered glass funnel. before making he final volume with water EXAMPLES FOR NASAL DROPS : Ephedrine hydrochloride nasal drops , Phenylephrine nasal drops , Oxymetazoline nasal drops , Betamethasone nasal drops.
FORMULATION METHOD OF PREPARATION : Simple solution method is employed for the preparation of nasal drops, because most of the drugs and additives used are water soluble. Ingredients type 1.Vehicles: Purified water 2.Tonicity adjustment: Sodium chloride, dextrose 3.Buffer: Phosphate buffer (pH -6.5) 4.Preservatives: Chlorobutonol(0.5%) , benzalkonium chloride (0.01 to 0.05%), Aromatic alcohols (0.5 to 0.9%) DISPENSING: Nasal drops are generally dispensed in small (10-15 ml capacity) clear or ambered coloured bottle with a dropper fitted with rubber teat. But now a days, nasal drops are dispensed in small, fluted plastic containers made up of polyethylene with “built in droppers” (bottle previously sealed with dropper ).
Nasal drops should be used with in month (four weeks) after opening the seal of the containers . If any unused amount of nasal drops is present , that should be discarded after one month , to avoid contamination from microorganisms , if it is stored for longer time . STORAGE : Nasal drops should be stored in cool place. LABEL: Nasal drops should bear necessary requirements of liquid dosage forms .in addition ,it should contain auxilliary labels like, FOR EXTERNAL USE ONLY . USE ONLY IN THE NOSTRIL OR FOR NASAL USE ONLY.
EXAMPLES Ephedrine Hydrochloride Nasal Drops B.P.C Phenylephirine Hydrochloride Nasal Drops EPHEDRINE HYDROCHLORIDE NASAL DROPSB.P.C : RX Ephedrine hydrochloride Sodium chloride Chlorbutol Water In this preparation, ephedrine hydrochloride acts as nasal decongestant. Sodium chloride is used to make nasal drops isotonic with nasal secretion.
Chlorbutol is used as preservative. Salts like ephedrine hydrochloride and sodium chloride are soluble in water, but chlorbutol is a volatile substance and it dissolves very slowly, in presence of salts at room temperature. Hence it requires vigorous shaking, with maximum amount of water. In order to achieve rapid dissolution, first chlorbutol is dissolved in hot water. During dissolving, conical flask should be stoppered to prevent the volatisation of chlorbutol . After cooling, other salts are dissolved and the solution should be passed through sintered glass funnel, before making the final volume with water.
PROCEDURE : Accurately weigh the chlorbutol and powder it . Select a small conical flask with suitable stopper. In conical flask, take ¾ th quantity of water and heat to 60°C without putting the stopper . Add chlorbutol to the hot water and quickly insert the stopper, prevent the volatsaition of chlorbutol and shake well, solution completes Allow the solution to cool (room temperature) and ephedrine hydrochloride and sodium chloride, dissolve them by stirring and filter the solution through sintered glass funnel or muslin cloth Transfer the filtrate to a measure and adjust the final volume with water DISPENSING: Ephedrine hydrochloride is light sensitive, therefore transfer the solution to the amber coloured , small glass or plastic bottle 10-15 ml capacity, close it thoroughly with rubber closure, polish, label and supply with dropper DIRECTION: To be instilled into nostrils ,as directed STORAGE : Store in a cool and dark place .
Liniments Liniments are solutions or mixture of various substances in oil, alcoholic solution of soap, or emulsions, intended for external application. They are applied with rubbing to the affected areas and that is why they were once called embrocations. Liniments are usually applied to the skin with friction and rubbing, the oil and soap base providing for ease of application and massage. Alcoholic liniments are intended generally for their rubefacient, counterirritant, mildly astringent and penetrating effects. They penetrate the skin readily than the oil base. Therefore, oily liniments are milder in their action but are more useful when massage is desired. Some liniments are solely used as protective coating depending on the ingredients in the preparation. Liniments should not be applied on broken skin. Liniments usually contain methyl salicylate, menthol and camphor in their preparations.
Camphor Liniment, NF, BP Other Names: Linimentum Camphoras or Camphorated Oil Formula: • Camphor 200 g • Cottonseed Oil 800 g • To make 1000 g Preparation Place the cottonseed oil into a suitable dry flask or bottle, heat on a steam bath, add camphor and stopper the container securely. Agitate to dissolve the camphor without further heating. Uses: Mild counterirritant for inflamed joints, sprains, rheumatism and in other inflammatory conditions such as cold in throat and chest, in infants and children. Remarks: The liniment should never be prepared in an open dish, as much of the camphor will volatilize. Although “camphorated oil” is often applied to this liniment and also frequently to indicate “Camphor Injection” a sterile 10% solution of camphor in olive oil or other fixed oil and which is used hypodermically as a stimulant. The two products must not be confused.
Lotions Lotions are suspensions, emulsions, combination of emulsion- suspension or aqueous or non aqueous solutions designed to be applied to the unbroken skin without friction. They are used for their epidermic effect, such as local cooling, soothing, protective, drying or moisturizing properties depending upon the ingredients used. Formulation: The therapeutics agents included in lotions are antifungal, anti inflammatory, anti infective, anti pruritic, scabicidal agents, parasiticides and local anesthetics. Many times they are simple solutions, while others contain insoluble solids such as calamine, sulphur or zinc oxide. Suspension type of lotions are referred to as shake lotions. Bentonite, sodium carboxymethyl cellulose are widely used as suspending agents in such lotions. Natural gums such as acacia or tragacanth are not suitable as suspending agent for lotions because of their sticky and irritation nature.
Lotions may also be o/w emulsions stabilised by emulsifying agents. Lotion may also contain substances such as glycerin or alcohol. Glycerin retains the moist film on skin for prolonged period of time and it also promotes adherence of the formulation on the skin surface. The evaporation of the alcohol after application produces a cooling effect in inflammation conditions and leave a protective layer on the skin surface. Solution should be labeled as ‘for external use only’. Apply without friction on intact skin, If applicable, shake well before use.
Calamine Lotion, USP Other Name: Lotio Calaminae Formula: Calamine Zinc Oxide Glycerin Bentonite Liquefied Phenol Sodium Citrate Calamine lotions is used as a topical protectant. Calamine lotion is having pink colour. It is used as astringent and protective for obtaining relif from sunburn, insect bite and other similar irritations. The pink colour helps to disguise the presence of lotion on skin. Zinc oxide is used as an astringent and produce s weak antimicrobial action. The antimicrobial and astringent actions of zinc oxide are due to the release of zinc. Zinc is released from zinc oxide on hydrolysis in the acidic moisture of the skin. Bentonite is a natural colloidal hydrated aluminium silicate. It is pale buff coloured powder. It is insoluble in water, swells nearly 12 times of its bulk and forms magma with desirable rheological characters. Hence it is used as suspending agent. Sodium citrate acts as a buffer and maintains the pH within limits appropriate toskin application.
It is also helps in the suspending action of bentonite and prevents frothing on shaking the preparation. Liquefied phenol acts as an antiseptic, preservative, and local anesthetic. Glycerin is used as soothing agent and make the preparation more viscous for the proper application of skin. It is also used as emollient and humectant. Rose water gives a good odour to the preparation. Calamine (Zinc oxide and ferric oxide) Astringent, Protective Zinc Oxide Astringent, weak antimicrobial agent Bentonite (Colloidal hydrated aluminium silicate) Suspending agent Sodium Citrate Buffer and maintain pH Phenol Antiseptic, preservative Glycerin Soothing agent, humectant Rose water Vehicle, Flavouring agent
Procedure: 1. Calamine, zinc oxide and bentonite are triturated with a solution of sodium citrate in about 3/4th quantity of rose water. 2. Liquefied phenol and glycerin are added to produce the required volume. 3. The preparation is shaken to ensure uniform distribution. 4. The preparation is then transferred to a bottle. Category: Topical protective. For external use only.
Enema Enema are aqueous or oily solutions, suspensions or emulsions of medicaments intended for rectal administration, to cause bowel evacuation, to bring about local or systemic therapeutic action or to instill x ray contrast medium for examination of the lower bowel. Enemas can be broadly of two types: 1. Evacuant enemas or cleaning enemas 2. Retention enemas. Evacuant enemas or cleaning enemas Evacuant enemas or cleaning enemas are employed to clean the bowel either to allow better visualisation or for administration of radio contrast material during diagnosis or to decrease the chance of contamination when bowel surgery is indicated. For diagnosis of lower bowel, barium sulphate enema is given as radio contrast media. The volume of evacuant enema may be as much as one litre. Such large volume enema should be warmed to body temperature before administration. If the enema is too cold, intestinal cramping may occur, and if is too hot it may damage the intestinal mucosa.
The mechanism of action of evacuant enema depends upon the ingredients present in it. If tape water is used for evacuation of bowel, it acts by stimulating peristalsis due to their large volume. Enemas containing substances like sodium phosphate, sodium biphosphate acts by causing osmotic retention of water in bowel. The evacuation effect of soft soap and terpentine oil is due to their local irritation. Ingredients like mineral oil, olive oil, glycerin and soft soap are used to lubricate the bowel. Retention enemas: Retention enemas are used for local or systemic effects and their volume do not normally exceed 100 ml. These are very much suitable for patients in whom the oral route must be avoided because of age, mental status or physiological condition. They are especially helpful in infants and geriatric patients who have difficulty in swallowing. Retention enema are used to administer anthelmentics (quassia), Anti inflammatory agents (hydrocortisone) etc.
Enemas should be packed in colour, screw capped glass bottles. Example: Rx Soap Enema INF Soft Soap Purified water Warm to make 100ml. Soft soap is formed by saponification of higher free fatty acid with sodium or potassium hydroxides. It acts as evacuant enema due to its local irritation and lubricating properties. Procedure: Dissolve soft soap in warm purified water. It is used for bowel cleaning. 500 ml injected through rectum and it should be warmed up to body temperature before use.
Collodions Collodions are liquid preparations containing pyroxylin in a mixture of ethyl ether and ethanol. A soft brush is used to apply the preparation to the skin. When the solvent evaporates it leaves a film of pyroxylin on the surface. 5% pyroxylin is used in nonmedicated colloidion. Pyroxyline is nitrated cellulose obtained by the action of a mixture of nitric and sulphuric acids on cotton. The nonaqueous solution of pyroxylin in ether-alcohol is collodion. They consist film forming substance, NITROCELLULOSE (Pyroxylin) in volatile solvents like alcohol , ether and acetone. Collodions are applied to skin, to close the small wounds ,abrasions and cuts. It is also used to hold the surgical dressings in place and to keep medicaments in contact with skin,for longer time(for sustained release of medicament). Collodions are applied either by brush or applicator.
Classification Type - 1 Non-medicated Collodions: Contain only “Flexible collodion ”. It is a solution of colophony and castor-oil in a mixture of pyroxylin , ether and alcohol ( collodion base). USES: These collodions are used for protecting small cuts and abrasions Type – 2 Medicated Collodions: Contain medicament along with flexible collodion . They provide prolonged contact between the skin and the medicament. USES: These collodions provide sustained source of keratolytic agents like,salicylic acid in the tretment of corns and warts. eg . Salicylic acid collodion. When collodions are mixed with castor oil and camphor it is termed as flexible collodions. Colophony is added to improve adhesion. Flexible collodion have several advantages like it can be used on the joints and movable part of the body with out the danger of cracking. Collodions are dispensed in small, amber colored (light resistant),well closed containers(as they contain highly volatile solvents like ether and alcohol).
Compounding: The solutions are prepared by shaking ingredients with solvent in a closed container. If any impurity is present, it is removed by decantation. It is used for external use only and it is inflammable
Preparation of Collodions Collodion USP Definition: Collodion contains not less than 5% of pyroxylin by weight. Formula: Pyroxylin 40g Ether 750ml Alcohol 250ml To make about 1000ml Preparation: Dissolve the pyroxylin in the ether and alcohol in a closed container. Possible Uses: As a protective to seal small wounds. Also in the preparation of medicated collodion.
Salicylic acid Collodion – B.P.C Rx Salicylic acid Flexible Collodion Flexible Collodion IP Pyroxylin Colophony Castor oil Alcohol(90%) Solvent Ether Compounding: 1. Add pyroxylin, colophony, castor oil in alcohol. Add ether and shake in closed container to produce solution. 2. Keep the solution aside and decant it to get clear solution 3. Adjust the volume with ether . Used as keratolytic

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monophasic liquid dosage forms.pptx

  • 1.
    Monophasic liquid dosageform Monophasic liquid dosage form refers to liquid preparation containing two or more components in one phase system, it is represent by true solution. •The component of the solution which is present in a large quantity is known as "solvent", whereas the component present in a small quantity is termed as "solute". Water is mainly used as solvent for majority of monophasic liquid dosage forms. A solution is homogenous because the solute is in an ionic or molecular form of subdivision.
  • 2.
    Monophasic liquid dosageforms are available as:- 1 .Liquid for internal use e.g. Syrup, Elixirs, Linctus, Drops and draughts. 2. Liquid for external use, which are of two types: a)Liquid to be applied to the skin e.g. liniments, and lotions etc. b)Liquid meant for body cavities e.g. gargles, throat paints, mouth washes, eye drops, eye lotions, ear drops, nasal drops, sprays and inhalations.
  • 3.
    Monophasic liquid dosage forms Liquidfor internal use Eg: Syrup, Elixirs, Linctus, Drops and draughts. Liquid for external use Liquid to be applied to the skin Eg: liniments, and lotions b)Liquid meant for body cavities Eg: gargles, throat paints, mouth washes, eye drops, eye lotions, ear drops, nasal drops, sprays and inhalations.
  • 4.
    Advantages of Monophasicliquid dosage forms • It is easier to swallow, therefore easier for children and old age people. • Facilitate absorption of drug faster than solid dosage form as drug is already in solution form.
  • 5.
    • It ishomogenous therefore give uniform dose than suspension or emulsion which need shaking. • Simple and fast to formulate • It can be administered by various routes : Oral, Parenteral (injection),enema for rectal use, otic(ear), nasal and ophthalmic preparation.
  • 6.
    Disadvantage • They arebulky, so difficult to transport and store. • Water is commonly use vehicle, which is prone to microbial growth. So addition of preservative is needed. • When expose to direct sunlight it may undergo hydrolysis, so need to store in cool and dark place. • Drug stability reduce by hydrolysis or oxidation. So, they have shorter expire date than solid dosage form. • Other major sign of drug instability are color change, Precipitation, microbial growth etc.
  • 7.
    Additives used inMonophasic Dosage form: Stabilizers: The compounds that protect the formulation from chemical degradation or microbial spoilage are termed as stabilizers. Antioxidants and preservatives are good stabilizers which are used in pharmacy. Stabilizers Preservatives Antioxidant
  • 8.
    Antioxidants: Antioxidants are thecompounds which prevent oxidation of the drug by different mechanisms. Oxidation of the drug is the most serious change. A large variety of drugs undergo oxidation degradation they are: Ascorbic acid, Heparin, Reserpin, Neomycin, Vitamin A, D & E etc. Every time a molecule is oxidized another molecule simultaneously gets reduced.
  • 9.
    Another classification ofantioxidants are
  • 10.
    The oxidants aremostly used in food, drug and cosmetic preparations, Other antioxidants used are: Benzoin Citric acid Malic acid etc. Malic acid is used as a rancidity retardant for oils and fats. Synergists: Synergists are compounds that enhance the overall effectiveness of the antioxidant compounds. This is achieved in the following ways: a. Complexation of the trace metals that catalyse the oxidative breakdown. b. Decreasing the oxygen stability of the solutions. The use of antioxidant to prevent oxidation is a popular practice but sometimes they shows toxicity. Eg: Thiol Derivatives. Choice of antioxidants: Following should be taken care while selecting antioxidants: 1. Must be nontoxic 2. Must not interfere with organoleptic property of the product 3. Inert in nature 4. Solubility should be proper.
  • 11.
    Colouring agents: A colouringis any substance that is added to change formulation colour. One of the most obvious ways to influence the way a product looks is to add colouring agents. Colorants or coloring agents are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms. These range from “natural” and artificial colours. Natural Colour A growing number of natural food colourings are being commercially produced, partly due to consumer concerns surrounding synthetic colourings. Some examples include: • Caramel colouring, made from caramelized sugar, used in cola products and also in cosmetics. • Annatto, a reddish-orange dye made from the seed of the Achiote. • A green dye made from chlorella algae. • Cochineal, a red dye derived from the cochineal insect, Dactylopius coccus. • Betanin extracted from beets. • Turmeric • Saffron • Paprika • Elderberry
  • 12.
    Pharmaceutical preparations arecolored for following reasons: 1) Increases acceptability 2) For identification - It helps to identify a product in it manufacturing and distribution stages 3) Stability purpose - Some of the insoluble colors or pigments have the additional benefit when used in tablet coatings or gelatin shells of providing useful opacity, which can contribute to the stability of light‐sensitive active materials in the tablet or capsule formulation.
  • 13.
    Ideal properties ofa colorant • Non-toxic and have no physiological activity. • Free from harmful impurities • Unaffected by light, tropical temperatures, hydrolysis and micro‐organisms and, therefore, be stable on storage. • Unaffected by oxidizing or reducing agents and pH changes. • Compatible with medicaments and not interfere with them. • Ready solubility in water is desirable in most cases but some oil‐soluble and spirit‐soluble colors are necessary. • Does not interferes with the tests and assays to which the preparations containing it are subject. • Free from objectionable taste and odour.
  • 14.
    Artificial colouring The coloursbelow are known as “Primary Colours”, when they are mixed to produce other colours, those colours are then known as “Secondary Colours”. *Brilliant Blue, E133 (Blue shade) * Indigotine, E132 (Dark Blue shade) * Fast Green, E143 (Bluish green shade) * Allura Red AC, E129 (Red shade) * Erythrosine, E127 (Pink shade) * Tartrazine, E102 (Yellow shade) * Sunset Yellow, E110 (Orange shade) Inorganic or mineral colors Stability towards light is an important characteristic displayed by this materials, some of which have a useful opacifying capacity, e,g. Titanium dioxide.
  • 15.
    • Dyes andLakes Colour additives are available for use in drug formulations as either “dyes” or “lakes”. Dyes dissolve in water, but are not soluble in oil. Dyes are manufactured as powders, granules, liquids or other special purpose forms. They can be used in beverages, dry mixes, baked Goods, dairy products, pet foods and a variety of other products. Lakes are the combination of dyes and insoluble material. Lakes are not oil soluble, but are oil dispersible. Lakes are more stable than dyes and are ideal for colouring products containing fats and oils or items lacking sufficient moisture to dissolve dyes. Typical uses include coated tablets, cake and donut mixes, hard candies and chewing gum.
  • 16.
    ARTIFICIAL COLOURANTS Colouring agentDescription Colour Erythrosine Solid,fine powder Red Sunset Yellow Solid,fine powder Reddish Orange tartrazine Solid,fine powder Light orange Ponceau Solid,fine powder Red Allura red Solid,fine powder Deep red amaranth Solid,fine powder Rediish brown Indigo carmine Solid,fine powder Bluish brown Brilliant blue Solid,fine powder Bluish violet Quinoline yellow Obtained from coal tar Yellow to orange powder
  • 17.
    Colouring agent DescriptionColour Paprika Clear dark red oily liquid, Dark red Annatto Crystalline powder Bright Yellow To Orange red Caramel Thick liquid Dark brown Carotene Powder, crystals Red to Brown Curcumin Crystal form Orange yellow Riboflavin Fine powder in needle form Whitish yellow Carmine Powder form Bright red Curcumin Crystal form Orange yellow NATURAL COLOURANTS
  • 18.
    Flavouring agents: A flavor,as used in the pharmaceutical industry for inactive ingredients, refers to natural or artificial tastes, which may include fragrances and colors of the flavoring. Flavors are used for orally consumed products such as syrups, chewable tablets, suspensions, or gums in order to make the bitter taste of the medicine more palatable, as well as imparting a beneficial therapeutic effect. Pharmaceutical flavors are available in liquid or powder form, in a variety of concentrations, formulations and sizes. Standard formulas are available as certified kosher, organic, vegan, all-natural, natural/artificial, artificial and sugar-free.
  • 19.
    Flavouring agents areadded to increase patient acceptance. The four basic taste sensations are salty, sweet, bitter and sour. It has been proposed that certain flavours should be used to mask these specific taste sensations. Example: Clove oil, citric and syrup, glycerin, rose oil, orange oil, menthol etc
  • 20.
    Natural flavouring substancesare extracted from plants, herbs and spices, animals, or microbial fermentations. Essential oils and oleoresins that are created by solvent extract with the solvent removed, herbs, spices and sweetness are all natural flavourings. Natural flavourings can be either used in their natural form or processed form for human consumption and they cannot contain any nature-identical or artificial flavouring substances.
  • 21.
    Artificial flavouring agentsare chemically similar to natural flavourings but are more easily available and less expensive. However, one drawback is that they may not be an exact copy of the natural flavourings they are imitating like amyl acetate which is used as banana flavouring or ethyl butyrate for pineapple. Nature-identical flavouring agents are the flavouring substances that are obtained by synthesis or are isolated through chemical processes. There chemical make-up of artificial flavourings is identical to their natural counterparts. These flavouring agents cannot contain any artificial flavouring substances.
  • 22.
    Chemical Odor Diacetyl, acetylpropionyl,acetoin Buttery Isoamyl acetate Banana Benzaldehyde Bitter almond, cherry Cinnamaldehyde Cinnamon Ethyl propionate Fruity Methyl anthranilate Grape Limonene Orange Ethyl decadienoate Pear Allyl hexanoate Pineapple Ethyl maltol Sugar, cotton candy Ethylvanillin Vanilla Methyl salicylate Wintergreen Manzanate Apple
  • 23.
    Gargles: Gargles are aqueousand hydroalcoholic solution which is used to treat or prevent throat infection. It is used in the posterior region of mouth by agitating the solution with exhaled air to produce local effect in the throat and these are not to swallowed in large amount. They are dispensed in concentrated form with directions for dilution with warm water. They are brought into intimate contact with the mucous membrane of the throat and allow to remain for few moments. Formulation: The commonly used active ingredients in gargle include Antiseptics, Analgesics, Astringents, and Alkalizing agent. Common drugs include phenol, thymol, menthol, methyl salicylate, povidone- iodine etc. Phenol and thymol is generally present in small concentration for its antibacterial activity. Astringent helps to restore tune of relaxed throat and also relieves dryness by stimulating salivation.
  • 24.
    Some gargles likethe Phenol Gargle and Phenol and Potassium Chlorate Gargle are official in BPC. Phenol gargle is 5% v/v solution of phenol and glycerin (16% w/w phenol and 84% w/w glycerin) in water containing amaranth dissolved in chloroform water. Gargles ought to have acceptable organoleptic properties and should be designed to act fast because of short contact periods. At the same time they should not be irritating to the mucous membranes of the oral cavity. Glycerin is the choice of vehicle for gargles, the reasons are as follows: a. Due to viscosity, it keeps medicament in contact with membraneous lining of throat for long period. b. Acts as demulcent c. The sweet taste of glycerin with aromatic substances in gargle gives characteristics flavor. d. It can increase the solubility of drug in the system.
  • 25.
    The following ingredientsare used in the formulation of Gargles Drugs Antiseptics, antibiotics etc Colouring Agents Amaranth, Patent blue V Flavouring Agents Peppermint oil Sweetening Agents Sucrose Viscolizers Glycerin Preservatives Phenol, thymol Vehicles Water, chloroform water
  • 26.
    Potassium Chlorate andPhenol Gargle Rx Potassium Chlorate Liquefied Phenol Patent Blue V Water Potassium chlorate and phenol gargle BPC is used as an astringent and antimicrobial. Potassium chlorate acts as a mild astringent and liquefied phenol acts as an antimicrobial agent Potassium chlorate is soluble in water and phenol is miscible with water. Therefore this gargle is prepared by simple dissolution of potassium chlorate in water followed by liquefied phenol and finally addition of patent blue V. Category: Astringent, antimicrobial Dilute 10 times with warm water before use.
  • 27.
    Mouth washes These areaqueous solutions with a pleasant taste and odour used to make clean and deodorise the buccal cavity. Generally they contain antimicrobial agents, alcohols, glycerin, sweetening agents, flavouring agents and colouring agents. Mouth washes are formulated either in ready to use form or in concentrated form. Mouth wash in concentrated form are required to be diluted as per directions on label. A pH of 5 – 9.5 appears to be safe range with 6.5 – 7 being optimum for liquids for oral use.
  • 28.
    Ingredients used inthe formulation of mouth washes are Ingredients Category Examples Drugs Antibacterial agents Phenols, thymols, tannic acid Astringents Zinc sulphate Antiseptics Hexitidine Viscolizers/ Humectants Glycerin, sorbitol Surfactants Tweens, Spans, SLS Sweeteners Saccharin Flavours Peppermint, cinnamon Colorants Amaranth Vehicles Water, Alcohol
  • 29.
    Mouth Washes Cosmetic Mouthwashes Therapeutic Mouthwashes Mouth washesare used as a dosage form for a number of specific problems in the oral cavity. Mouthwashes containing antibacterials: These reduce bacterial population of the mouth Mouthwashes containing fluorides: These helps to reinforce the fluoride layer of the enamel of the teeth Mouthwashes containing astringents: These precipitate the protein of microorganisms and thereby helps in throat infections. These are formulated to reduce bad breath through the use of antimicrobial and / or flavouring agents. Eg: Soap based mouthwashes. Cosmetic mouthwashes remove superficial for particles and debris and they are very refreshing Classifications:
  • 30.
    Therapeutic mouthwashes areused for the following reasons: a. Used in the treatment of stomatitis b. Mouthwash containing pilocarpine is used in xerostoma (dry mouth) etc Nowadays mouthwash solution tablets are available. These tablets are dissolved in water and used as mouthwash.
  • 31.
    Compound Sodium ChlorideMouth Wash BPC Rx Sodium Chloride Sodium bicarbonate Peppermint emulsion, concentrated Chloroform water, double strength Water Compound sodium chloride mouthwash is used as an astringent. Sodium chloride and sodium bicarbonate are soluble in water. Concentrated peppermint emulsion and chloroform water are miscible with water in the quantities specified in the formula. Therefore this mouthwash is prepared by dissolving the solid ingredients and simple mixing is sufficient. In this preparation peppermint emulsion acts as a flavouring agent. Chlorofom acts as a preservative and sweetener. Dilute with an equal volume of water before use.
  • 32.
    Throat paint Throat paintsare the viscous liquid preparations used for the mouth and throat infections. Glycerin is commonly used as a base. Paints can be applied onto skin and mucous membranes. Throat paints are made viscous because, they should remain in contact with mucous membrane, to exert its medicinal action for longer time. Therefore glycerine is commonly used as a base(vehicle) due to its viscous nature and its agreeable sweet taste and cooling effect. Throat paints are applied to the affected part with the help of camel hair brush or by cotton plug, twisted at the tip of plastic stick. They should be applied as such, without dilution with water.
  • 33.
    Medicaments used inThroat paints: 1) Astringents : Tannic acid, Boric acid 2) Antiseptics : Iodine, Crystal violet 3) Anti- infectives : Phenol 4) Analgesics : Clove oil, Potassium permangan Examples for throat paints : Mandl ’ s paint(compound iodine paint) Tannic acid- glycerine throat paint Phenol- glycerine throat paint ate
  • 34.
    Advantages : Throatpaints are useful in the treatment of pharyngitis, laryngitis , tonsillitis thrush, abcess of throat and ulcerative stomatitis . Due to high viscous nature, they retain the drug for longer time on affected part of the throat. Disadvantages : Throat paints initiate salivation. Hence the patient has to spit again and again till salivation subsides. This makes it uncomfortable to the patients It is very difficult to apply the throat paint to the inner parts of the mouth and throat by the fingers. Hence always requires camel hairbrush or cotton plug, twisted at the tip of plastic stick for application of throat paint. This makes it difficult and uncomfortable to the patients .
  • 35.
    Formulation : Alongwith the medicaments, it contains high proportions of glycerine and other sweetening agents , flavouring agents, stabilizers and preservatives. Method of preparations: They are preparations by simple solution method , with the aid of heat. Dispensing : Throat paints should be dispensed in air tight , coloured (amber coloured -light sensitive), narrow or wide mouthed bottle in order to distinguish them from the preparations meant for internal use and they should be supplied with camel hairbrush(throat brush.)
  • 36.
    Direction: Throat paintsshould contain the direction to the patients as, Apply with camel brush, as directed. To prevent their volatalisation at higher temperature , they should be stored in a cool and dark place.
  • 37.
    COMPOUND IODINE THROATPAINT I.P Synonym : Mandl’s paint Rx Potassium iodide Iodine Alcohol Purified water Peppermint oil Glycerine Iodine is slightly soluble in water, but it is soluble in presence of potassium Iodide and forms polyiodides. These polyiodides are highly soluble in water and hence produce monophasic liquid. Alcohol(90%) acts as cosolvent , to increase the solubility of iodine. It is also used to dissolve peppermint oil, which acts as flavouring agent. Glycerine is viscous in nature hence Mandl’s paint will remain in contact with mucous membrane of throat for longer time, It also acts as humectant and soothing agent. .
  • 38.
    Procedure: Triturate iodinein glass mortar, to get fine powder and accurately weigh the required amount of iodine. Dissolve potassium iodine in water. To this solution, add iodine powder by stirring . Dissolve peppermint oil and half of the portion of the portion of glycerine in alcohol. Add this solution to the above iodine and potassium iodide solution ,with continuous stirring and adujust the final volume with remaining portion of glycerine . Uses : Mandl ’ s paint is used in the treatment of pharyngitis, laryngitis, tonsillitis and sore throat.
  • 39.
    Ear drops Ear dropsare medicated liquid preparations and these are used for instillation in to ear with the help of a dropper. The solution are prepared in water, glycerin, propylene glycol or alcohol. Vehicle like glycerin and propylene glycol are preferred as they increase contact time and soften the wax. Aqueous solutions are less popular because the secretions in the ear are mainly fatty and aqueous solutions do not easily mix with them. Uses of Ear Drop 1. Antibacterial. 2. Softening the wax. 3. Mild infections
  • 40.
    The main classesof drugs used in ear drops are a. Bacterial infections are sometimes treated with antibiotics. Examples are: • Ciprodex ear drops containing ciprofloxacin and dexamethasone • Gentisone HC ear drops containing gentamicin and hydrocortisone • Ciproxin HC ear drops containing ciprofloxacin and hydrocortisone b. Analgesics: Salicylic acid c. Antiseptics: Phenol d. Astringents: Alumenium Sulphate. For softening the ear wax: Hydrogen peroxide, magnesium sulphate.
  • 41.
    Eg: Boric Acid EarDrop Rx Boric Acid Industrial Alcohol Purified Water QS Make ear drop Two to three drops to be instilled in to ear, as directed. Boric acid is a week germicide (antiseptic), which inhibits the growth of certain bacteria and fungi. It is also used to treat otorrhoea. It is nonirritating in nature. Therefore it is suitable for penetrating ear drops. Boric acid is slightly soluble in water but is freely soluble in industrial alcohol (alcohol 95%). Alcohol also acts as preservative.
  • 42.
    Procedure: Ear drops areprepared by simple solution method with or without aid of heat. 1. Accurately weighed boric acid is dissolved in industrial alcohol 2. To the above solution add 3/4th of total volume of purified water and mix thoroughly. 3. Filter the solution to remove any foreign particles or undissolved substances. 4. Transfer this content to a measuring cylinder and add sufficient amount of water to make up the final volume. Storage: Transfer the solution to a small glass or plastic bottle of 10-15 ml capacity, close it thoroughly with rubber closure and aluminum cap, polish, label and supply with a dropper. For external use only or for ear use only
  • 43.
    Nasal drops Nasal dropsare aqueous preparations of drugs, intended for instillation into nostrils with the help of a dropper. They are generally used for their antiseptic, local analgesic or vasoconstriction properties. Medicaments commonly used are: Medicaments commonly used are: Anti-inflammatory : corticosteroids, betamethasone. Sympathaomimetics :Ephedrine hydrochloride Decongestants :phenylephrine, oxymetazole,Tetrahydrozoline hydrochloride , oxymetazole hydrochloride
  • 44.
    Nasal drops aregenerally formulated to resemble the nasal secretion. Hence nasal drops should be isotonic and slightly buffered, to maintain pH 5.5 – 7.5 . The viscosity of nasal drops should be similar to the viscosity of the nasal secretions. Therefore viscosity of nasal drops is adjusted with the help of thickening agents like methylcellulose, hydroxy propyl methylcellulose For preparation of nasal drops, generally aqueous vehicles is used . Oils are not preferred as vehicles, because oily drops inhibit the ciliary movement of the nasal mucosa and even causes lipoidal pneumonia (drops of oil enters the lungs). Since the nasal drops is instilled in to nasal cavity , that will be in contact with mucous membrane of nose , it should be clarified by passing through sintered glass funnel. before making he final volume with water EXAMPLES FOR NASAL DROPS : Ephedrine hydrochloride nasal drops , Phenylephrine nasal drops , Oxymetazoline nasal drops , Betamethasone nasal drops.
  • 45.
    FORMULATION METHOD OFPREPARATION : Simple solution method is employed for the preparation of nasal drops, because most of the drugs and additives used are water soluble. Ingredients type 1.Vehicles: Purified water 2.Tonicity adjustment: Sodium chloride, dextrose 3.Buffer: Phosphate buffer (pH -6.5) 4.Preservatives: Chlorobutonol(0.5%) , benzalkonium chloride (0.01 to 0.05%), Aromatic alcohols (0.5 to 0.9%) DISPENSING: Nasal drops are generally dispensed in small (10-15 ml capacity) clear or ambered coloured bottle with a dropper fitted with rubber teat. But now a days, nasal drops are dispensed in small, fluted plastic containers made up of polyethylene with “built in droppers” (bottle previously sealed with dropper ).
  • 46.
    Nasal drops shouldbe used with in month (four weeks) after opening the seal of the containers . If any unused amount of nasal drops is present , that should be discarded after one month , to avoid contamination from microorganisms , if it is stored for longer time . STORAGE : Nasal drops should be stored in cool place. LABEL: Nasal drops should bear necessary requirements of liquid dosage forms .in addition ,it should contain auxilliary labels like, FOR EXTERNAL USE ONLY . USE ONLY IN THE NOSTRIL OR FOR NASAL USE ONLY.
  • 47.
    EXAMPLES Ephedrine Hydrochloride NasalDrops B.P.C Phenylephirine Hydrochloride Nasal Drops EPHEDRINE HYDROCHLORIDE NASAL DROPSB.P.C : RX Ephedrine hydrochloride Sodium chloride Chlorbutol Water In this preparation, ephedrine hydrochloride acts as nasal decongestant. Sodium chloride is used to make nasal drops isotonic with nasal secretion.
  • 48.
    Chlorbutol is usedas preservative. Salts like ephedrine hydrochloride and sodium chloride are soluble in water, but chlorbutol is a volatile substance and it dissolves very slowly, in presence of salts at room temperature. Hence it requires vigorous shaking, with maximum amount of water. In order to achieve rapid dissolution, first chlorbutol is dissolved in hot water. During dissolving, conical flask should be stoppered to prevent the volatisation of chlorbutol . After cooling, other salts are dissolved and the solution should be passed through sintered glass funnel, before making the final volume with water.
  • 49.
    PROCEDURE : Accurately weighthe chlorbutol and powder it . Select a small conical flask with suitable stopper. In conical flask, take ¾ th quantity of water and heat to 60°C without putting the stopper . Add chlorbutol to the hot water and quickly insert the stopper, prevent the volatsaition of chlorbutol and shake well, solution completes Allow the solution to cool (room temperature) and ephedrine hydrochloride and sodium chloride, dissolve them by stirring and filter the solution through sintered glass funnel or muslin cloth Transfer the filtrate to a measure and adjust the final volume with water DISPENSING: Ephedrine hydrochloride is light sensitive, therefore transfer the solution to the amber coloured , small glass or plastic bottle 10-15 ml capacity, close it thoroughly with rubber closure, polish, label and supply with dropper DIRECTION: To be instilled into nostrils ,as directed STORAGE : Store in a cool and dark place .
  • 50.
    Liniments Liniments are solutionsor mixture of various substances in oil, alcoholic solution of soap, or emulsions, intended for external application. They are applied with rubbing to the affected areas and that is why they were once called embrocations. Liniments are usually applied to the skin with friction and rubbing, the oil and soap base providing for ease of application and massage. Alcoholic liniments are intended generally for their rubefacient, counterirritant, mildly astringent and penetrating effects. They penetrate the skin readily than the oil base. Therefore, oily liniments are milder in their action but are more useful when massage is desired. Some liniments are solely used as protective coating depending on the ingredients in the preparation. Liniments should not be applied on broken skin. Liniments usually contain methyl salicylate, menthol and camphor in their preparations.
  • 51.
    Camphor Liniment, NF,BP Other Names: Linimentum Camphoras or Camphorated Oil Formula: • Camphor 200 g • Cottonseed Oil 800 g • To make 1000 g Preparation Place the cottonseed oil into a suitable dry flask or bottle, heat on a steam bath, add camphor and stopper the container securely. Agitate to dissolve the camphor without further heating. Uses: Mild counterirritant for inflamed joints, sprains, rheumatism and in other inflammatory conditions such as cold in throat and chest, in infants and children. Remarks: The liniment should never be prepared in an open dish, as much of the camphor will volatilize. Although “camphorated oil” is often applied to this liniment and also frequently to indicate “Camphor Injection” a sterile 10% solution of camphor in olive oil or other fixed oil and which is used hypodermically as a stimulant. The two products must not be confused.
  • 52.
    Lotions Lotions are suspensions,emulsions, combination of emulsion- suspension or aqueous or non aqueous solutions designed to be applied to the unbroken skin without friction. They are used for their epidermic effect, such as local cooling, soothing, protective, drying or moisturizing properties depending upon the ingredients used. Formulation: The therapeutics agents included in lotions are antifungal, anti inflammatory, anti infective, anti pruritic, scabicidal agents, parasiticides and local anesthetics. Many times they are simple solutions, while others contain insoluble solids such as calamine, sulphur or zinc oxide. Suspension type of lotions are referred to as shake lotions. Bentonite, sodium carboxymethyl cellulose are widely used as suspending agents in such lotions. Natural gums such as acacia or tragacanth are not suitable as suspending agent for lotions because of their sticky and irritation nature.
  • 53.
    Lotions may alsobe o/w emulsions stabilised by emulsifying agents. Lotion may also contain substances such as glycerin or alcohol. Glycerin retains the moist film on skin for prolonged period of time and it also promotes adherence of the formulation on the skin surface. The evaporation of the alcohol after application produces a cooling effect in inflammation conditions and leave a protective layer on the skin surface. Solution should be labeled as ‘for external use only’. Apply without friction on intact skin, If applicable, shake well before use.
  • 54.
    Calamine Lotion, USP OtherName: Lotio Calaminae Formula: Calamine Zinc Oxide Glycerin Bentonite Liquefied Phenol Sodium Citrate Calamine lotions is used as a topical protectant. Calamine lotion is having pink colour. It is used as astringent and protective for obtaining relif from sunburn, insect bite and other similar irritations. The pink colour helps to disguise the presence of lotion on skin. Zinc oxide is used as an astringent and produce s weak antimicrobial action. The antimicrobial and astringent actions of zinc oxide are due to the release of zinc. Zinc is released from zinc oxide on hydrolysis in the acidic moisture of the skin. Bentonite is a natural colloidal hydrated aluminium silicate. It is pale buff coloured powder. It is insoluble in water, swells nearly 12 times of its bulk and forms magma with desirable rheological characters. Hence it is used as suspending agent. Sodium citrate acts as a buffer and maintains the pH within limits appropriate toskin application.
  • 55.
    It is alsohelps in the suspending action of bentonite and prevents frothing on shaking the preparation. Liquefied phenol acts as an antiseptic, preservative, and local anesthetic. Glycerin is used as soothing agent and make the preparation more viscous for the proper application of skin. It is also used as emollient and humectant. Rose water gives a good odour to the preparation. Calamine (Zinc oxide and ferric oxide) Astringent, Protective Zinc Oxide Astringent, weak antimicrobial agent Bentonite (Colloidal hydrated aluminium silicate) Suspending agent Sodium Citrate Buffer and maintain pH Phenol Antiseptic, preservative Glycerin Soothing agent, humectant Rose water Vehicle, Flavouring agent
  • 56.
    Procedure: 1. Calamine, zincoxide and bentonite are triturated with a solution of sodium citrate in about 3/4th quantity of rose water. 2. Liquefied phenol and glycerin are added to produce the required volume. 3. The preparation is shaken to ensure uniform distribution. 4. The preparation is then transferred to a bottle. Category: Topical protective. For external use only.
  • 57.
    Enema Enema are aqueousor oily solutions, suspensions or emulsions of medicaments intended for rectal administration, to cause bowel evacuation, to bring about local or systemic therapeutic action or to instill x ray contrast medium for examination of the lower bowel. Enemas can be broadly of two types: 1. Evacuant enemas or cleaning enemas 2. Retention enemas. Evacuant enemas or cleaning enemas Evacuant enemas or cleaning enemas are employed to clean the bowel either to allow better visualisation or for administration of radio contrast material during diagnosis or to decrease the chance of contamination when bowel surgery is indicated. For diagnosis of lower bowel, barium sulphate enema is given as radio contrast media. The volume of evacuant enema may be as much as one litre. Such large volume enema should be warmed to body temperature before administration. If the enema is too cold, intestinal cramping may occur, and if is too hot it may damage the intestinal mucosa.
  • 58.
    The mechanism ofaction of evacuant enema depends upon the ingredients present in it. If tape water is used for evacuation of bowel, it acts by stimulating peristalsis due to their large volume. Enemas containing substances like sodium phosphate, sodium biphosphate acts by causing osmotic retention of water in bowel. The evacuation effect of soft soap and terpentine oil is due to their local irritation. Ingredients like mineral oil, olive oil, glycerin and soft soap are used to lubricate the bowel. Retention enemas: Retention enemas are used for local or systemic effects and their volume do not normally exceed 100 ml. These are very much suitable for patients in whom the oral route must be avoided because of age, mental status or physiological condition. They are especially helpful in infants and geriatric patients who have difficulty in swallowing. Retention enema are used to administer anthelmentics (quassia), Anti inflammatory agents (hydrocortisone) etc.
  • 59.
    Enemas should bepacked in colour, screw capped glass bottles. Example: Rx Soap Enema INF Soft Soap Purified water Warm to make 100ml. Soft soap is formed by saponification of higher free fatty acid with sodium or potassium hydroxides. It acts as evacuant enema due to its local irritation and lubricating properties. Procedure: Dissolve soft soap in warm purified water. It is used for bowel cleaning. 500 ml injected through rectum and it should be warmed up to body temperature before use.
  • 60.
    Collodions Collodions are liquidpreparations containing pyroxylin in a mixture of ethyl ether and ethanol. A soft brush is used to apply the preparation to the skin. When the solvent evaporates it leaves a film of pyroxylin on the surface. 5% pyroxylin is used in nonmedicated colloidion. Pyroxyline is nitrated cellulose obtained by the action of a mixture of nitric and sulphuric acids on cotton. The nonaqueous solution of pyroxylin in ether-alcohol is collodion. They consist film forming substance, NITROCELLULOSE (Pyroxylin) in volatile solvents like alcohol , ether and acetone. Collodions are applied to skin, to close the small wounds ,abrasions and cuts. It is also used to hold the surgical dressings in place and to keep medicaments in contact with skin,for longer time(for sustained release of medicament). Collodions are applied either by brush or applicator.
  • 61.
    Classification Type - 1Non-medicated Collodions: Contain only “Flexible collodion ”. It is a solution of colophony and castor-oil in a mixture of pyroxylin , ether and alcohol ( collodion base). USES: These collodions are used for protecting small cuts and abrasions Type – 2 Medicated Collodions: Contain medicament along with flexible collodion . They provide prolonged contact between the skin and the medicament. USES: These collodions provide sustained source of keratolytic agents like,salicylic acid in the tretment of corns and warts. eg . Salicylic acid collodion. When collodions are mixed with castor oil and camphor it is termed as flexible collodions. Colophony is added to improve adhesion. Flexible collodion have several advantages like it can be used on the joints and movable part of the body with out the danger of cracking. Collodions are dispensed in small, amber colored (light resistant),well closed containers(as they contain highly volatile solvents like ether and alcohol).
  • 62.
    Compounding: The solutions areprepared by shaking ingredients with solvent in a closed container. If any impurity is present, it is removed by decantation. It is used for external use only and it is inflammable
  • 63.
    Preparation of Collodions CollodionUSP Definition: Collodion contains not less than 5% of pyroxylin by weight. Formula: Pyroxylin 40g Ether 750ml Alcohol 250ml To make about 1000ml Preparation: Dissolve the pyroxylin in the ether and alcohol in a closed container. Possible Uses: As a protective to seal small wounds. Also in the preparation of medicated collodion.
  • 64.
    Salicylic acid Collodion– B.P.C Rx Salicylic acid Flexible Collodion Flexible Collodion IP Pyroxylin Colophony Castor oil Alcohol(90%) Solvent Ether Compounding: 1. Add pyroxylin, colophony, castor oil in alcohol. Add ether and shake in closed container to produce solution. 2. Keep the solution aside and decant it to get clear solution 3. Adjust the volume with ether . Used as keratolytic